Humanitarian Device Exemption (HDE)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the Original HDE to get an up-to-date view of this device.

• Trade Name: IBV VALVE SYSTEM
• Classification Name: one-way air-leak valve
• Generic Name: one-way air-leak valve
• Applicant: Gyrus Acmi, Inc.; 6675 185th ave. ne; redmond, WA 98052
• HDE Number: H060002
• Supplement Number: S004
• Date Received: 07/23/2010
• Decision Date: 09/14/2010
• Product Code: OAZ [ Registered Establishments with OAZ ]
• Advisory Committee: Anesthesiology
• Supplement Type: normal 75 day track
• Supplement Reason: other
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval of the post-approval study for the device.